1. Field of the Invention
The present invention relates to a package for packaging a protection cover with at least one channel for use in an endoscope.
2. Description of the Related Art
An endoscope system has been widely utilized for providing diagnostic and therapeutic indications for coeliac cavities of patients and for inspecting an inside of a mechanical structure. To this end, there have been developed various kinds of endoscopes. For instance, in order to inspect or treat the oesophagus, stomach and duodenum, upper endoscopes have been utilized. Further, colonoscopes have been developed to examine colons and sigmoidoscopes have been proposed to inspect rectums and sigmoid colons. When effecting the endoscopic procedure, an inserting portion of the endoscope has to be inserted into a cavity, so that the outer surface of the insertion section of the endoscope is contaminated. Such a contaminated endoscope could not be successively used for another patients. Therefore, once the endoscope is used to diagnose and/or treat a patient, it is necessary to clean the endoscope. Of course, the cleaning of the endoscope requires a substantial time and during this cleaning time, it is impossible to perform the endoscopic procedure. In order to mitigate such a waiting time, it is necessary to prepare a large number of endoscopes. However, endoscopes are rather expensive, so that it is practically difficult to prepare a large number of endoscopes particularly in a small hospital or clinic. Therefore, in almost all hospitals and clinics, in practice, after the endoscope has been used for examining a patient, the endoscope is immediately cleaned. Typically, this cleaning requires several minutes to ten minutes. In order to effect the complete washing and sterilization, the cleaning has be to performed for several tens of minutes.
Further, the endoscope has various channels such as an air channel, a water channel, a suction channel, a forceps channel which extend along the insertion section from its proximal end to its distal end, and these channel are connected via tubes to respective devices such as an air supply pump, a water supply pump, a water suction pump and an air suction pump. These channels are subjected to contact with living tissues and liquids, so that in order to completely clean these channels, the endoscope cleaning time is liable to be much longer. Then, the endoscope could not be utilized efficiently. In a large hospital or clinics, a large number of endoscopes may be prepared in order to mitigate the problem of cleaning time. However, this solution results in an increase in operating cost. Further, in a small clinic, it is practically impossible to prepare a number of expensive endoscopes.
Moreover, when the endoscope is cleaned, some chemicals are used. The chemicals are toxic and might injure operators. Further, the damage of the environment due to the chemicals has to be avoided as far as possible. This also results in an increase in the operating cost. It should be noted that the endoscope might be broken during the cleaning and the usable time of the endoscope is liable to be shortened by the cleaning.
It is a matter of course that if the endoscope is not cleaned sufficiently, there might be a danger of infection not only for patients, but also for doctors and operators who are brought into contact with the endoscope.
In order to avoid the above explained various problems, it has been proposed to cover the endoscope with a disposable protection sheath having channels formed therein. For instance, U.S. Pat. Nos. 4,721,097, 4,741,326, 4,869,238, 4,991,564, 4,991,565, 5,050,585 disclose various kinds of the protection sheath having at least one channel. In U.S. Pat. No. 4,646,722, there is shown a system in which the endoscope is covered with a protection sheath, while a tube having channels formed therein is inserted into the U-shaped cutout formed in an outer surface of the endoscope along a longitudinal axis thereof. Upon diagnosis, the insertion section of the endoscope is covered with the protection sheath, and after the inspection, the sheath is removed from the insertion section and is then discarded. Therefore, it is no more necessary to clean the endoscope after every the inspection.
In the above mentioned U.S. Patent Specifications, the protection sheath is constructed to cover only the insertion section of the endoscope, but does not cover an operation section of the endoscope. It should noted that the operation section of the endoscope is treated by hands of doctor and operators and thus is brought into contact with the living tissues and liquids of a patient. Therefore, in order to attain a perfect disinfection, it is necessary to cover the operation section of the endoscope. In European Patent Publication No. 0 349 479 A1, there is disclosed an endoscope system, in which not only the insertion section, but also the operation section of the endoscope are covered with a disposable protection cover-like member. That is to say, the protection cover-like member comprises a sheath portion for covering the insertion section of the endoscope and a bag portion for covering the operation section, the sheath portion and bag portion being integrally formed. The operation section of the endoscope is usually provided with various operating members such as angle knobs and optical systems adjusting members. The endoscope shown in the above mentioned European Patent Publication No. 0 349 479 A1 is of a colonoscope type, so that the angle knobs are not provided. However, the focus adjusting ring has to be operated during the inspection. To this end, an aperture is formed in the bag portion of the protection cover-like member at a position corresponding to the focus adjusting ring. In this case, in order to operate the ring easily, it is preferable to form a large aperture. Then, the contamination via the aperture is liable to be large. In order to avoid such a drawback, in European Patent Publication No. 0 341 719 A1, there is proposed another endoscope system, in which an insertion section of an endoscope is covered with a disposable protection bag which is mated or joined with the protection sheath in order to prevent the contamination at the junction of the sheath and the bag. In this known system, the angle knobs are detachably secured to a shaft extending from a housing of the operation section and the shaft is protruded from the protection bag through an aperture formed in the bag. Such a diameter of the shaft is much smaller than a diameter of the angle knobs, a size of the aperture can be made much smaller than the angle knobs. Therefore, a possibility of the contamination via the aperture formed in the bag can be reduced as compared with a case in which a large aperture through which the angle knobs are projected from the bag is formed in the bag.
However, in the usual endoscopes, the angle knobs for moving the distal end of the insertion section in the up and down directions as well as in the right and left directions are secured to the shaft and could not be removed from the shaft during usual usage. Therefore, in the known endoscope, the couplings of the angle knobs with the shaft are effected in various ways, and a set of angle knobs for a certain endoscope could not be secured to a shaft of another endoscope. In the usual endoscope system, this does not cause any problem, because the angle knobs and shaft are not decoupled from each other. However, in the endoscope system disclosed in the above European Patent Publication No. 0 341 719 A1, this results in a serious problem. In an endoscope procedure area, there are arranged various endoscopes of different types, and therefore, once the angle knobs are removed from the shaft extending from the operation section of the endoscope, it is rather difficult to select correct angle knobs. If angle knobs are not forceably mated with the shaft, the angle knobs and/or shaft might be broken.
In the system including the endoscope and the disposable protection sheath, if a pin hole is formed in the sheath, contamination arises via the pin hole. In order to avoid such a problem, respective protection sheath have to be checked in a factory and only sheaths which have no pin hole are shipped or forwarded. However, known sheaths are not formed to effect such a pin hole check easily, so that in practice, the pin hole check has not been performed sufficiently. Therefore, there is a danger that a protection sheath having a pin hole is used for the endoscope procedure. Therefore, just before the usage of the protection sheath, it is preferable to effect the pin hole check at the endoscope procedure site. However, in the known system disclosed in the above mentioned prior art references, this pin hole check could not be carried out easily.
Further, in the known endoscope system using the disposable protection sheath, the various channels are provided within the sheath. In practice, these channels are formed by flexible tubes and these tubes extend within the sheath from a proximal end to a distal end. At these proximal and distal ends, ends of these tubes are fixed to the sheath so that they can share a predetermined mutual positional relation at these ends. However, substantial portions of the tubes except for the proximal and distal ends are not fixed, but extend freely. Usually these tubes have a circular cross section, and thus relatively large spaces are formed between these tubes. Therefore, when the insertion section is bent by suitably operating the angle knobs, one or more tubes might move relatively largely. Then, the tubes might resist the smooth bending movement of the insertion section, and the distal end of the insertion section might be bent in a direction which is different from a desired direction. Apparently, this causes problem in handling the endoscope during the inspection.
In order to utilize the above endoscope sheath in a proper condition, it is necessary to pay proper consideration for an accommodation and maintenance method of the endoscope sheath or the like. To this end, there has been proposed means shown in, for example, U.S. Pat. No. 4,997,084. This means concerns a method of packaging an endoscope sheath, and more particularly, a bag capable of accommodating the sheath by a holder having a larger diameter than an aperture of the endoscope sheath in a straight condition.
In this prior packaging method, however, there are various defects. That is, the endoscope sheath is constructed by combining a long channel and a plurality of tube members in view of construction, so that if the insertion sheath sections of the endoscope are accommodated so as to overlap themselves in case of accommodating the endoscope sheath in a package having a spiral recess, or if the long channel is accommodated while remaining cross-sectional shape of the channel at the time of usage, the overlapped sheath portions are increased in volume. Then, it is necessary to increase the height of the package itself, so that the package has to be large.
As described above, since the endoscope sheath is, generally, of disposal, in a large hospital or clinics having a large number of patients, a large number of endoscope sheaths must be prepared. Then, in the case of the large package, even if a great number of large packages are overlapped one on the other for reserving, a large or wide reserving space must be provided.
In order to avoid the above described large reserving space, there has been provided a method in which the long insertion sheath is spirally wound in turn to accommodate it in the package. In this way, when the insertion sheath section is spirally wound, a lumen such as an endoscope insertion channel formed in the insertion sheath is kinked and remains in the kinked condition or the lumen is subjected to an unexpected injury, or when the endoscope is inserted into the endoscope insertion channel of the insertion sheath, the insertion sheath is broken, so that when the insertion sheath is combined with the endoscope for the usage in the medical operation field, interference arises.